Loolwa Khazzoom: In your book, you mentioned that doctors don’t necessarily know the effectiveness of the prescription drugs they’re prescribing for chronic pain; yet because they’re doctors, they’ll say “Oh, it has to work on you, and if it doesn’t work, it’s all in your head”. Please elaborate.

Paula Kamen: It is surprising to a lot of patients, as it was to me, just how many drugs are prescribed “off-label” – meaning that the FDA never specifically approved that drug for the treatment of pain. I know with my specific ailment, Chronic Daily Headache, the great majority of drugs prescribed are off-label and have not been adequately studied.

The rationale for this prescription is based on what doctors call anecdotal evidence: They might have given an anti-seizure drug to some people and found, just anecdotally, that it helped those patients’ headaches. So the doctors are now prescribing tons and tons of the drug, without scientifically studying its treatment of headaches.

In my case, it just seemed like this strange witch’s brew of drugs: I was getting anti-seizure drugs, antique anti-depressants from the 1950s, blood pressure medication, and tranquilizers – most commonly dispensed in the treatment of women.

For years, I thought that I was the only one not getting relief, that I was “unresponsive,” as doctors called it – that I had an unresponsive metabolism or brain chemistry or something. So I was surprised to interview other patients, to go to medical conferences and interview doctors and just see how random so much of this is.

A lot of the drugs I was prescribed had extreme side effects that became worse than my actual chronic headache. So even though I still have a headache non-stop, I don’t take any drugs. They have such strong side effects, and they really don’t work that well anyway.

Among other things, I had extreme weight gain: I gained fifty pounds in about a year. Even worse, I had a totally foggy brain; I was like a zombie walking around. All I wanted to do was sleep all the time. I remember working at a temp job and actually falling asleep at the desk.

The treatments for short-term pain often don’t work in the long run. Drugs like Advil often give rebound headaches over time, if taken frequently. Opioids work sometimes, but over time, the effectiveness is diminished. You then have to take more and more, and sometimes you get side effects from that.

In Western medicine, it’s difficult to treat pain that’s not just short-term. Western medicine is wonderful if you’re having a baby. As I’ve just discovered through my own experience, it’s great for going into labor. When they offered me the epidural, they knew what they were doing. But for pain that’s long-term, especially pain that’s constant, they’re really bad at being able to treat it.

PK: Doctors often seemed surprised and became defensive when the drugs they prescribed didn’t work for me. Doctors often expect to be omnipotent, and they often lack the ethic of admitting limitations. It just takes a whole different level of humility that doctors aren’t often trained to have – to admit there are times when you simply don’t know something. Instead of just saying, “I don’t know,” or, “There aren’t better drugs,” there’s this tendency to just say, “You’re not responsive.”

LK: Even though they know that they are prescribing something without any scientific studies done for a particular ailment? They still have the attitude, “You have to be responsive, otherwise it’s all in your head”?

PK: I should clarify that with these off-label drugs, there often have been shorter, smaller-scale studies, but just not at the level that the FDA requires for approving a drug in the treatment of a particular condition.

LK: I think patients expect and trust that the drugs have been well-researched. We put our hands in the FDA, as if it’s Mom and Dad taking care of us, looking out for us. So we might think, “Oh X, Y, and Z had the research done, so it’s the safe way to go.”

In the case of alternative medicine, we may think, “That’s just quackery. Nobody has done studies on it. We don’t know what the hell’s going on. It’s more scientifically-documented when it comes to drugs.” But what you’re saying is that the pain medications are not necessarily as scientifically-sound as we me may believe.

PK: Not necessarily. Some of them have been studied, but not necessarily, because there is so much off-label prescribing of drugs. There are risks involved, especially with new drugs. While those drugs have been tested for the intended use, doctors immediately are prescribing them to treat numerous other conditions.

For example, Lyrica is an anti-seizure medication. Doctors gave it to me for chronic pain, right after it came out. I developed the worst rash on my arms and legs – like in a horror movie. With the new drugs, there’s a special danger, because they are marketed aggressively to the doctors; they are expensive; and there really hasn’t been testing for other purposes, just because the drugs are so new.

PK: Just because something is a pharmaceutical doesn’t necessarily mean that it’s been comprehensively tested for a patient’s specific ailment. It could have been approved for something else – say for depression or to prevent seizures – but not necessarily had comprehensive testing for chronic pain, or for a specific individual’s type of chronic pain. As such, the effectiveness of it might be weak, at best.

In my research, I was surprised by how many of these off-label drugs only help a minority of Chronic Daily Headache patients. The drugs have not been tested as much as I would have thought for my specific ailment. Also over the long term, they have a tendency to poop out. Even if you do find one of these off-label drugs to help, there is a tendency for them to stop working over the long-term.

LK: How can it even be legal for a doctor to prescribe a drug for something that hasn’t been tested yet?

PK: It’s just not legal for the pharmaceutical company to advertise it for that purpose. Botox got in huge trouble for the sales reps telling doctors “Oh, it’s good for headaches.” So they are allowed to sell it as an anti- wrinkle treatment, but they can’t sell it as headache treatment.

LK: So how is it that doctors end up prescribing it as a headache treatment?

PK: That’s a good question. Some doctor who might be prescribing it, as in the case of Botox, might start documenting, “I’ve noticed there’s been some headache relief in some of my patients.” The word spreads, and there might be some small-scale studies about it. But there’s often a lack of long-term studies, and the studies that are done might not be that big.

Paula Kamen, a Chicago-based journalist, is the author of All In My Head: An Epic Quest to Cure an Unrelenting, Totally Unreasonable and Only Slightly Enlightening Headache, and most recently, Finding Iris Chang (on bipolar disorder). Her book on chronic pain is one of my top three picks for chronic pain reads.

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Comments

I have read _All in My Head_ three times now, I think. Paula Kamen’s story helped me realize that I wasn’t alone, that I wasn’t going crazy or imagining side effects, and that I needed to get a better doctor who listened to me!

In telling my neurologist about strange side effects I’d attributed to the anti-seizure medication he’d put me on, he just frowned and dismissed my concern with an “Oh, I’ve never heard of that happening…” It’s frustrating even to remember that scene!

Here’s hoping the new doctor(s) will be a bit more understanding. Thanks for this great interview!

As a medical writer (with chronic pain as one of my specialties) and a chronically ill person myself, I think the article is too heavily against off-label prescriptions. Yes, drugs are used off-label for indications they aren’t very effective against. On the other hand, companies often cannot afford to conduct critical trials that would scientifically demonstrate the efficacy of a drug in a particular condition.

Me, I would be in wheelchair, perhaps even in a nursing home with dementia and unable to care for myself, if it wasn’t for three off-label drugs: one meant for drug detoxification (which I use at about 1/10 of the normal dose), one meant for cortical myoclonia (which I use at about 1/10 of the dose meant for that indication) and one meant for post-stroke vasospasm (which I used at 1/24 of the normal dose and which still retains its efficacy, even though I do no longer use it).

These drugs have stopped my illness progression. I don’t have any side effects, and in fact the drugs likely help prevent several chronic conditions, even cancer. If off-label prescribing was illegal, I would have no life, no future. I would either be dead, or a forgotten shell of a human being unable to do anything at all.

Natalie Warden December 30th, 2008

Maija: I didn’t feel that Paula was advocating to ban off-label prescribing at ALL. What I took from her comments was a wish to change the doctor-patient interactions, in which doctors “lack the ethic of admitting limitations” (her words). So it’s not that they shouldn’t do the prescribing, but they should be up front about the fact that this is something they are trying that MIGHT work, and not get defensive or label the patient “unresponsive” when it doesn’t work for them. Really, I think all she is hoping for is honesty: for doctors to get comfortable with admitting when they don’t know something, rather than making the patient feel like they are somehow weird or at fault for the fact that a treatment is not working.